NCT05989464

Self-Collected Swabs for Primary Human Papilloma Virus (HPV) Screening

Self-Collected Swabs for Primary Primary Human Papilloma Virus (HPV) Screening

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 84 (estimated)
• Sponsor: University of Hawaii · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators will assess whether implementing a self-swab protocol for primary Human Papilloma Virus (HPV) testing is an effective method to increase cervical cancer screening in a sample of unscreened women in Hawaii. The findings of this study may support adoption of HPV self swab protocols both at Kalihi Palama Health Center (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.

Detailed description

Cervical cancer is the fourth most common cancer worldwide. In the United States, the majority of cervical cancer diagnoses are made in individuals who have not been adequately screened. Cervical cancer prevention relies on adequate screening using one of three methods: pap smear cytology, Human Papilloma Virus (HPV) testing alone, or a combination of these two tests. These screening tests are performed by clinicians comfortable performing a pelvic exam, most commonly a women's health provider. Currently, less than 60% of individuals with an indication for cervical cancer screening in the Kalihi Palama Health Center (KPHC) are up-to-date on their cervical cancer screening test. Even patients who regularly see their primary care provider (PCP) can face major barriers to attending an appointment with a women's health provider. These barriers include practical issues such as inability to take time off, cost concerns, and lack of transportation. Emotional barriers include embarrassment, lack of privacy, and discomfort associated with the test. Self-collected swabs for HPV testing is a proven strategy for populations with low screening rates. Prior studies have demonstrated increased screening rates for transgender men, African American women in the Mississippi Delta, and Women From Appalachian Ohio. Studies also reported patient evaluations of the self-sampling to be comfortable, convenient, and user-friendly; and one study found a majority preference of self-sampling over practitioner-sampling for the next screening. Self-collected samples have also demonstrated good concordance with practitioner-collected cervical samples, as seen in multiple studies. The multiple benefits of self-swabbing without compromising screening accuracy enables the HPV self swab protocol to be an effective alternative for under screened populations. In fact, multiple countries have adopted national guidelines for self-sampled HPV screening for either under screened populations or as primary screening for all women, and more countries are piloting self-sampling to date. In this study, the investigators will assess whether implementing a self-swab protocol for primary HPV testing is an effective method to increase cervical cancer screening in a sample of unscreened women in Hawaii. The findings of this study may support adoption of HSS protocols both at (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.

Conditions

• HPV

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Self-swab for genital HPV	Participants will insert a swab in the vagina to collect a sample for HPV testing.

Timeline

• Start date: 2023-08-08
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2023-08-14
• Last updated: 2023-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study